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Glossary
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Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) American College of Surgeons Eastern Cooperative Oncology Group Radiation Therapy Oncology Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00377156 |
RATIONALE: Stereotactic radiation therapy can send x-rays directly to the tumor and cause less damage to normal tissue. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether stereotactic radiation therapy is more effective with or without whole-brain radiation therapy in treating patients with brain metastases.
PURPOSE: This randomized phase III trial is studying stereotactic radiation therapy and whole-brain radiation therapy to see how well they work compared with stereotactic radiation therapy alone in treating patients with brain metastases.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors Breast Cancer Cancer-Related Problem/Condition Lung Cancer Prostate Cancer |
Procedure: radiation therapy Procedure: stereotactic radiosurgery |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | Phase III Randomized Trial of the Role of Whole Brain Radiation Therapy in Addition to Radiosurgery in Patients With One to Three Cerebral Metastases |
Estimated Enrollment: | 528 |
Study Start Date: | July 2006 |
Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Active Comparator
Patients undergo stereotactic radiosurgery (SRS)
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Procedure: stereotactic radiosurgery
No administration details available
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Arm II: Experimental
Patients undergo SRS as in arm I. Within 14 days, patients then undergo whole-brain radiotherapy 5 days a week for 2.5 weeks.
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Procedure: radiation therapy
Patients undergo radiation therapy 5 days a week for 2.5 weeks
Procedure: stereotactic radiosurgery
No administration details available
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (18 to 59 vs 60 and over), extracranial disease (controlled for ≤ 3 months vs controlled for > 3 months), and number of brain metastases (1 vs 2 vs 3). Patients are randomized to 1 of 2 treatment arms.
Quality of life, functional independence, and neurocognitive status are assessed at baseline, at the beginning of each treatment, at weeks 6 and 12, and then at 6, 9, 12, 16, 24 , 36, 48, and 60 months.
PROJECTED ACCRUAL: A total of 528 patients will be accrued for this protocol.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of cerebral metastases meeting the following criteria:
Metastases must be from a histologically confirmed extracerebral site (e.g., lung, breast, prostate)
PATIENT CHARACTERISTICS:
Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Study Chair: | Paul D. Brown, MD | Mayo Clinic |
Investigator: | Kurt A. Jaeckle, MD | Mayo Clinic |
Investigator: | Richard L. Deming, MD | Mercy Therapeutic Radiology Associates, PC at Mercy Medical Center - Des Moines |
Investigator: | Elana Farace, PhD | Milton S. Hershey Medical Center |
Investigator: | Bruce Pollock, MD | Mayo Clinic |
Study Chair: | Anthony Asher, MD, FACS | Carolina Neurosurgery and Spine Associates |
Investigator: | Fred G. Barker, MD | Massachusetts General Hospital |
Study Chair: | Larry Kleinberg, MD | Sidney Kimmel Comprehensive Cancer Center |
Study Chair: | Anthony Asher, MD, FACS | Carolina Neurosurgery and Spine Associates |
Study ID Numbers: | CDR0000499633, NCCTG-N0574, ACOSOG-N0574 |
Study First Received: | September 13, 2006 |
Last Updated: | January 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00377156 |
Health Authority: | Unspecified |
cognitive/functional effects adult tumors metastatic to brain stage IV breast cancer stage IV prostate cancer stage IV non-small cell lung cancer |
male breast cancer recurrent breast cancer recurrent prostate cancer recurrent non-small cell lung cancer |
Thoracic Neoplasms Non-small cell lung cancer Prostatic Diseases Genital Neoplasms, Male Skin Diseases Breast Neoplasms Urogenital Neoplasms Central Nervous System Neoplasms Genital Diseases, Male Recurrence |
Respiratory Tract Diseases Breast Neoplasms, Male Lung Neoplasms Lung Diseases Neoplasm Metastasis Prostatic Neoplasms Carcinoma, Non-Small-Cell Lung Nervous System Neoplasms Breast Diseases |
Respiratory Tract Neoplasms Neoplastic Processes Neoplasms |
Pathologic Processes Neoplasms by Site Nervous System Diseases |